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Director, Global Regulatory Affairs (GRA) – CMC

Ironwood Pharmaceuticals is seeking a Director of Global Regulatory Affairs to lead CMC regulatory activities supporting their product development strategies in gastrointestinal healthcare.

Skills

  • Regulatory Affairs
  • Lead CMC submissions
  • Cross-functional collaboration
  • Project management
  • Strategic communication

Responsibilities

  • Lead development of CMC regulatory strategy for clinical-stage programs
  • Serve as regulatory representative at internal meetings
  • Provide strategic guidance to project teams
  • Initiate discussions with health authorities
  • Facilitate preparation for meetings with FDA, EMA, and others
  • Support Quality and CMC teams during GMP inspections
  • Coordinate and prepare CMC regulatory submissions

Education

  • Bachelor’s degree in Biology, Chemistry, or Pharmaceutical Sciences
  • Advanced degree preferred

Benefits

  • Restricted Stock Unit awards
  • Bonus or sales incentive program eligibility
  • 401(k) matching contributions
  • Medical, dental, vision benefits
  • Wellness stipends
  • Generous vacation/holiday schedule
To read the complete job description, please click on the ‘Apply’ button
Ironwood Pharmaceuticals Glassdoor Company Review
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CEO of Ironwood Pharmaceuticals
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Mark Mallon
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Average salary estimate

$219020 / YEARLY (est.)
min
max
$202000K
$236040K

If an employer mentions a salary or salary range on their job, we display it as an "Employer Estimate". If a job has no salary data, Rise displays an estimate if available.

What You Should Know About Director, Global Regulatory Affairs (GRA) – CMC, Ironwood Pharmaceuticals

Join Ironwood Pharmaceuticals as the Director of Global Regulatory Affairs (GRA) – CMC, based in beautiful Boston, Massachusetts. In this exciting leadership role, you’ll be at the forefront of our mission to redefine GI healthcare for patients in need. As part of a company recognized for innovations such as LINZESS®, the U.S. leader in its field, you'll lead the development of comprehensive regulatory strategies for clinical-stage programs. Your expertise will ensure that all CMC regulatory requirements are seamlessly integrated into our product development plans. With over 10 years of experience in Regulatory Affairs, particularly in the biopharmaceutical industry, you possess a strong track record in global submissions and registration of new drugs. Your role will involve collaborating with senior leadership and key stakeholders, driving effective regulatory actions, preparing for critical interactions with health authorities, and supporting quality during inspections. You'll communicate and guide internal teams toward achieving our corporate objectives, ensuring every step we take is in the best interest of our patients. If you're ready to make a real impact in the world of GI treatment and advance your career with a forward-thinking company, Ironwood Pharmaceuticals might be the perfect fit for you.

Frequently Asked Questions (FAQs) for Director, Global Regulatory Affairs (GRA) – CMC Role at Ironwood Pharmaceuticals
What are the key responsibilities of the Director, Global Regulatory Affairs (GRA) – CMC at Ironwood Pharmaceuticals?

The Director, Global Regulatory Affairs (GRA) – CMC at Ironwood Pharmaceuticals is tasked with leading the CMC regulatory strategies for clinical-stage programs, ensuring that all applicable regulations are integrated into product development plans. This role involves collaborating with team members, managing submissions to health authorities, and supporting inspections, all while fostering internal communication to achieve company goals.

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What qualifications are necessary for the Director, Global Regulatory Affairs (GRA) – CMC role at Ironwood Pharmaceuticals?

Candidates for the Director, Global Regulatory Affairs (GRA) – CMC position should have a Bachelor’s degree in a relevant science field, preferably with at least 10 years of experience in Regulatory Affairs within the biopharmaceutical industry. Proven experience in drug development and global regulatory submissions is essential, along with strong leadership and communication skills.

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How does the Director of Global Regulatory Affairs (GRA) – CMC contribute to Ironwood Pharmaceuticals’ mission?

The Director of Global Regulatory Affairs (GRA) – CMC plays a crucial role in advancing Ironwood Pharmaceuticals’ mission by developing robust regulatory strategies that align with the company’s goals. This involves proactive communication with health authorities and ensuring compliance throughout the product lifecycle, thereby facilitating the successful introduction of innovative treatments to the market.

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What is the importance of CMC regulatory strategies in drug development at Ironwood Pharmaceuticals?

CMC regulatory strategies are vital at Ironwood Pharmaceuticals because they ensure that all developmental activities for new drugs comply with applicable regulations. This helps mitigate risks, streamline processes, and enhances the efficiency of bringing innovative treatments to patients while maintaining high industry standards.

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What opportunities for career growth exist for the Director, Global Regulatory Affairs (GRA) – CMC at Ironwood Pharmaceuticals?

The Director, Global Regulatory Affairs (GRA) – CMC at Ironwood Pharmaceuticals has significant opportunities for career growth by leading impactful projects and collaborating with a multi-disciplinary team. This role not only enhances personal development through strategic decision-making but also positions the individual as a key leader in driving the company’s vision forward in the healthcare sector.

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Common Interview Questions for Director, Global Regulatory Affairs (GRA) – CMC
Can you explain your experience with global regulatory submissions for drug development?

In answering this question, highlight your specific experiences in preparing and managing global regulatory submissions, detailing the types of drugs you worked with and the regulatory bodies involved. Emphasize your strategic approach and any successful outcomes.

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How do you stay updated on the latest CMC regulations?

Share your methods for staying informed about regulatory changes, such as attending workshops, subscribing to industry publications, and participating in professional organizations. Mention how this proactive approach has benefited your previous roles.

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Describe a challenging regulatory compliance issue you faced and how you resolved it.

Provide a specific example of a compliance issue, focusing on your problem-solving process. Explain what steps you took, how you collaborated with your team, and the final outcome, showcasing your ability to navigate complex regulatory landscapes.

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What strategies do you utilize for effective communication with health authorities?

Discuss your communication strategies, such as clarity, establishing rapport, and understanding the regulatory objectives of health authorities. Illustrate this with examples of successful interactions you've had, focusing on the outcomes.

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How do you prioritize tasks when managing multiple CMC projects?

Talk about your organizational strategies such as using project management tools, creating timelines, and prioritizing based on deadlines and project importance. Offer insight into how this helps you maintain team alignment and project clarity.

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What leadership qualities do you believe are essential for the role of Director, Global Regulatory Affairs?

Enumerate essential leadership qualities like influence, empathy, strategic thinking, and effective communication. Provide examples of how you've demonstrated these qualities in your previous roles to drive team success.

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Can you provide an example of how you successfully collaborated with cross-functional teams?

Illustrate a specific situation where cross-functional collaboration was necessary, detailing your role and contributions. Focus on how you facilitated teamwork to achieve a shared objective and the successful results.

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How do you approach risk assessment in regulatory strategies?

Discuss your systematic approach to risk assessment, including identifying potential regulatory challenges and developing mitigation plans. Provide an example of how this has helped in past projects.

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What metrics do you use to measure the success of CMC regulatory submissions?

Mention the metrics you track, such as approval timelines, submission quality, and regulatory interaction outcomes. Explain how this data is utilized to improve processes and drive future regulatory strategies.

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How would you manage a sudden change in regulatory guidelines during a project?

Emphasize your adaptability and strategic thinking. Discuss how you would assess the impact of the changes, communicate with your team, and revise plans quickly to ensure project continuity and compliance.

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SALARY RANGE
$202,000/yr - $236,040/yr
EMPLOYMENT TYPE
Full-time, hybrid
DATE POSTED
December 3, 2024

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